Jaguar Health Inc. said that its unit Napo Pharmaceuticals has initiated the commercial launch of the FDA-approved oral mucositis prescription product Gelclair in the U.S.
FDA approved Itovebi (inavolisib) with palbociclib (Ibrance) and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, human epidermal growth-factor receptor 2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.
FDA approved an Investigational Device Exemption application to initiate a multi-center study for the treatment of recurrent cutaneous squamous cell carcinoma in immunocompromised patients using the Alpha DaRT.
FDA granted 510(k) clearance to GE HealthCare’s MIM Software tool to calculate the absorbed dose of radionuclides using a Monte Carlo method.
AML Express, a next-generation sequencing assay designed to provide rapid, comprehensive genetic profiling for patients with acute myeloid leukemia, was announced by NeoGenomics Inc.
PatientPoint, a digital health company, launched an interactive, in-office digital hub that delivers specialty-specific, customizable content and practice tools for clinicians, and allows for streamlined workflows, and enhanced collaboration across care teams.
Myriad Genetics Inc. and Ultima Genomics Inc. join to explore Ultima’s UG 100 sequencing platform and its ppmSeq technology to advance Myriad’s ability to offer groundbreaking clinical tests. Myriad has purchased a new UG 100 that will soon join other leading sequencing platforms in its Lab of the Future facility in South San Francisco.
FDA approved Opdivo (nivolumab) with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent Opdivo after surgery as adjuvant treatment, for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements.
FDA granted traditional approval to Retevmo (selpercatinib) for adult and pediatric patients two years of age and older with advanced or metastatic medullary thyroid cancer with a RET mutation, as detected by an FDA-approved test, who require systemic therapy.
FDA approved the Cologuard Plus test, a multitarget stool DNA test. The Cologuard Plus test is now approved for adults ages 45 and older who are at average risk for colorectal cancer.
